FDA 510(k) Application Details - K161072

Device Classification Name	Vinyl Patient Examination Glove   More FDA Info for this Device
510(K) Number	K161072
Device Name	Vinyl Patient Examination Glove
Applicant	ZIBO FLOURISH TRADING CO., LTD. NAQI ROAD, ZHANGDIAN DISTRICT ZIBO 255000 CN Other 510(k) Applications for this Company
Contact	KOU LINGLING Other 510(k) Applications for this Contact
Regulation Number	880.6250   More FDA Info for this Regulation Number
Classification Product Code	LYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2016
Decision Date	07/14/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review